Mabworks’ Obexelimab β Wins NMPA Approval as First Domestic NMOSD Therapy
Beijing Mabworks Biotech Co., Ltd. announced that the National Medical Products Administration (NMPA) has approved...
Product approvals
Astellas’ VENTANA CLDN18 Assay Wins NMPA Approval as First Companion Diagnostic for VYLOY
Astellas Pharma Inc. (TYO: 4503) announced that its VENTANA CLDN18 (43-14A) Assay has received approval...
3SBio’s Amdokitug Wins NMPA Approval for Moderate-to-Severe Plaque Psoriasis
Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. (SHA: 688336), a subsidiary of 3SBio Inc. (HKG: 1530), announced that...
Bio-Thera’s Gotenfia Wins European Approval as Simponi Biosimilar
Bio-Thera Solutions Inc. (SHA: 688177) announced that the European Commission (EC) has approved Gotenfia (BAT2506), its...
Novocure’s Optune Pax Wins FDA Approval for Pancreatic Cancer; Zai Lab China Rights in Play
Novocure Ltd. (NASDAQ: NVCR), Zai Lab Ltd.’s (NASDAQ: ZLAB, HKG: 9688) Swiss oncology partner, announced FDA clearance for...
Amgen’s UPLIZNA Wins European Approval for Generalized Myasthenia Gravis
Amgen Inc. (NASDAQ: AMGN) announced that the European Commission (EC) has approved UPLIZNA (inebilizumab) as an...
MSD’s Keytruda Wins FDA Approval for Platinum-Resistant Ovarian Cancer
Merck & Co. (MSD, NYSE: MRK) announced that the U.S. Food and Drug Administration (FDA) has...
Eli Lilly’s Jaypirca Wins NMPA Approval for CLL/SLL Post-BTK Inhibitor Therapy
Eli Lilly and Company (NYSE: LLY) announced that the National Medical Products Administration (NMPA) has approved...
Pfizer’s Cresemba Wins NMPA Pediatric Approval for Invasive Fungal Infections
Pfizer Inc. (NYSE: PFE) announced that the National Medical Products Administration (NMPA) has approved an indication...
Eli Lilly’s Omvoh Wins NMPA Approval for Crohn’s Disease and Ulcerative Colitis in China
The National Medical Products Administration (NMPA) has approved Eli Lilly and Company’s (NYSE: LLY) Omvoh (mirikizumab),...
Betta Pharma Secures NMPA Approval for Beizeting, First Domestic Pertuzumab Biosimilar in China
Betta Pharmaceuticals Co., Ltd. (SHE: 300558) announced that the National Medical Products Administration (NMPA) has...
Kelun-Biotech’s Jiatailai Secures Fourth NMPA Approval for HR+/HER2- Breast Cancer Indication
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. (HKG: 6990) announced that the National Medical Products Administration (NMPA)...
J&J Darzalex Faspro Gets NMPA Approval for Transplant-Eligible Myeloma Patients
Johnson & Johnson (J&J, NYSE: JNJ) announced that Darzalex Faspro (daratumumab and hyaluronidase-fihj) has received National...
Everest Medicines Files Velsipity for Ulcerative Colitis in China
Everest Medicines (HKG: 1952) announced it has submitted a marketing filing in China for Velsipity...
Keytruda Wins 20th China Approval for Endometrial Cancer in First-Line Setting
Merck & Co. (MSD, NYSE: MRK) announced that Keytruda (pembrolizumab) has received its 20th indication approval...
Bayer Nubeqa Gets NMPA Approval for Metastatic Prostate Cancer
Bayer AG (ETR: BAYN) announced that the National Medical Products Administration (NMPA) has approved Nubeqa (darolutamide)...
ZEISS ARTEVO Gets NMPA Approval for China Ophthalmology Market
ZEISS Medical Technology announced that the National Medical Products Administration (NMPA) has approved the ARTEVO...
Chiesi’s Juxtapid Wins NMPA Approval for Rare Cholesterol Disorder in China
Chiesi Group’s China unit announced that the National Medical Products Administration (NMPA) has granted marketing...
Novartis Cosentyx Wins NMPA Approval for Non-Radiographic Axial Spondyloarthritis
Novartis (NYSE: NVS) announced that the National Medical Products Administration (NMPA) has approved Cosentyx (secukinumab) for...